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06 - Innovating Food, Innovating the Law - Dario Dongo
 

06 - Innovating Food, Innovating the Law - Dario Dongo

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Piacenza, October 14, 2011 ...

Piacenza, October 14, 2011
"Innovating Food, Innovating the Law"
Conference

DARIO DONGO (Federalimentare, Italy)
Health claims, a troubled implementation and mixed stakeholders’ views on
Reg. EC no. 1924/2006

video: http://vimeo.com/31033738

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    06 - Innovating Food, Innovating the Law - Dario Dongo 06 - Innovating Food, Innovating the Law - Dario Dongo Presentation Transcript

    • Nutrition & Health Claims Reg. (EC) n. 1924/06 Avv. Dario Dongo © 2011 EU & Regulative Policies, Head Federalimentare dongo@federalimentare.it - GSM +39 335 7313 726
    • Health claims « A troubled implementation and mixed stakeholders views on Reg. (EC) n. 1924/2006 » Piacenza, October 13, 2011
    • Scope (1)
      • This Regulation shall apply to nutrition and health claims made in commercial communications , whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer (Art . 1.2)
      • All B2C information referring to food (and not, for example to a meal composition, or a complete diet)
      • Internet information is included
    • Scope (2)
      • Trademarks (registered brand )
      • Brand names (unregistered brand but well known on the market and protected at national level)
      • Fancy names (remaining category)
      • -> moratorium until 19.1.2022 for 1 and 2 previous 1.1.05
      • -> after 15 years, a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of this Regulation. (Art. 1.3)
    • Scope (3)
      • For generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health
      • -> eg. “digestives”, “cough sweets”, “healthy biscuits”
      • -> a possible derogation, via an appropriate procedure (Art. 1.4, 25. 2)
    • Definition: Claim
      • ‘ Claim ’ means any message or representation, in any form, including pictorial, graphic or symbolic representation,
      • which is not mandatory under Community or national legislation,
      • which states, suggests or implies that a food has
      • particular characteristics (Art. 2.2.1 )
    • General Principles for all Claims (1)
      • The use of nutrition and health claims shall not :
      • be false ,
      • ambiguous or
      • misleading ,
      • give rise to doubt about the safety and/or the nutritional, adequacy of other foods
    • General Principles for all Claims (2)
      • The use of nutrition and health claims shall not :
      • encourage or condone excess consumption of a food, the role and importance of the food (or of categories of food) and the contribution to the diet of the population in general or, as appropriate, of certain risk groups including children
    • Definition: Health Claims
      • ‘ Health claim ’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health (Art. 2.2.5, 13)
      • ‘ Reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease (Art. 2.2.6)
    • Art. 13.1 health claims
        • EFSA Opinions: Total 2.758 claims
          • 1 st batch: October 1 st 2009 : 521 claims
          • 2 nd batch: February 25 2010 : 416 claims
          • 3 rd batch: October 19 2010 : 808 claims
          • 4 th batch: April 08 2011 : 442 claims
          • 5 th batch : June 30 2011 : 536 claims
          • 6 th batch : July 28 2011 : 35 claims
      • A decision is still pending with regard to the scientific assessment of the botanical claims that were submitted under this process. Furthermore, claims for which additional data has been submitted under the ‘further assessment’ process will be assessed by EFSA at a later stage (expected: autumn this year )
    • Obstacles (1)
      • Building of art. 13 claims list:
        • Lack of common metodology for the presentation and justification of claims
        • Too strict tnterpretation of “scientifical substantation” by EC and EFSA = double blind clinical tests on healthy people
        • Confused process , without uniformity
        • Process delayed
    • Obstacles (2)
      • Scientific evaluation of claims:
        • Evaluation criteria. unclear and inappropriate in the nutritional/fisiological area
        • Same evaluation criteria and same standard for art. 13 and art. 14 claims
        • Botanical claims. lack of consistency with the approval procedure provided for traditional herbal medicines
        • Clinical data on patients are not considered
    • Troubles (1)
      • Pharmaceutical approach ( Food products are different of pharmaceutical ones)
      • EC mandate to EFSA is disproportionate and not adapted to the food research
      • Lack of information for consumers : lack of informed and awared choices (Distorsion of consumers information)
      Misunderstanding of the Regulation principles -> 80% rejection of pre-selected health claims
    • Troubles (2)
      • Scientific research shows diferent levels of evidence (intermediate, advanced)
      • Golden standards requirements hamper R&D and innovation
      • Food pyramid and dietary guidelines lack of evidence
      • Food Supplements . lack of security = uncontrolled information sources
    • EHPM view
      • Industry’s main concerns:
      • Piecemeal adoption of the lists
      • Lack of Impact Assessment
      • Lack of guidance/clarity on EFSA’s evaluation
      • lack of dialogue
      • Article 13 should benefit from a different assessment and authorisation process than Article 14 claims (recital 26)
      • http://www.ehpm.org/
    • European Parliament question (1)
      • Elisabetta Gardini (PPE), Mario Mauro (PPE) and other MEP’s question the EC about:
      • remarkable complexity of the implementation process = lack of clarity
      • 95 % authorisation requests for substances other than vitamins and minerals are expected to be rejected
      • Distortion of information to consumers = a large amount of information on the effects of vitamins and minerals but very little information on other substances
    • European Parliament question (2)
      • Given the impact of this regulation on health claims, will the Commission rectify these distortions of the market and of consumer information that are taking place?
      • http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+WQ+E-2011-005587+0+DOC+XML+V0//EN&language=EN
    • Definition: Nutrition Claims
      • ‘ Nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:
      • the energy (kcal) it provides; provides at a reduced or increased rate; or does not provide; and/or
      • the nutrients or other substances it contains; contains in reduced or increased proportions; or does not contain (Art. 2.2.4)
    • Nutrition claims
      • The nutrition claims’ list is too limited (i.e. GI claims are not provided)
      • Why to exclude other true indications which are noteworthy for consumers?
    • Industry position
      • Recognition of traditional values
      • Research, promotion and incentives
      • Innovation as a competition tool (in the global market)
      • C onsumers’ confidence to be gained on scientific based claims
      • Scientific criteria to be proportional to the true nature of food
    • Food supplement, the Italian approach
      • Directive 2002/46/EC: harmonization of FS sector
      • Operators must: guarantee product safety + inform about its plausible effects
      • Legislative Decree 21 of May 2004 : the nutritional or physiological effect must be stated in the FS labelling
      • With Regulation 1924/2006/EC , the physiological effect became an health declaration with the only obligation for producer to commercialize a safe product = FS can be inactive
      • Real need to harmonize the plausible effect with Regulation Claims
    • EMEA /EFSA
      • FoodDrinkEurope and Federalimentare ask for the same procedures to be applied from EFSA and EMEA
    • Thank you for your attention